Posts tagged ‘Training’

A new update to EU GMP Chapter 2 has been issued and comes into operation on 16th February 2014. Here is a summary of the main changes from the previous version Chapter 2 Personnel OLD. A copy of the new version can be found by clicking on the link Chapter 2 Personnel NEW. Read more

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At some point every year (or perhaps every 2 years) someone in a pharmaceutical organisation will say “It’s time to think about this year’s GMP training”. This statement will usually be received with little enthusiasm from those who hear it, but nevertheless a plan will be formed to deliver the training over the next 4 or 5 months or so. On the day of the training the majority of delegates will arrive with equally low levels of enthusiasm as the annual chore of GMP training begins. “Right – let’s make a start” the trainer will say, as the delegates think “well let’s get this over and done with” as they listen (whilst trying to stay awake) to the focus area of this year’s training – which is usually what they did so badly wrong last year! Read more

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From Parts 1, 2 and 3 of this post we have focused on the duties of the three key personnelnamed in EU GMP (the Head of Production, QC and the Qualified Person). We have also highlighted that there is no formal requirement for an Engineering Manager (or Department) AND a Quality Assurance Manager (or Department) in GMP. Most pharmaceutical manufacturing sites do actually have these people (and departments) and we have looked at the roles and responsibilities commonly performed by these in previous posts. There is also a final “key personnel” not named in GMP, namely the Human Resources Manager. Bearing in mind that in the manufacture and testing of medicines it is the employees themselves who have a massive impact on product quality and the quality systemthen the importance of the individual who looks after employees(usually the HR Manager) cannot be understated.Read more